The Global Product Development Lead - Px will be responsible for the successful development of diagnostic-related products (up to and including Phase 3 clinical trials) for the diagnosis of cancer. Create, implement, manage and execute the drug development plan.
Key Accountabilities:
- Work as part of a cross-functional team to create product development and commercialisation plans of PSMA related products.
- Lead cross-functional teams to deliver program and product development milestones up to end of Phase 3 clinical evaluation.
- Execute product development plans through end of Phase 3 within project timelines and budget.
- Oversee the Project Manager to apply project management best practice.
- Act as primary point of contact for the programs and maintain internal/external communication.
- Maintain up-to-date documentation of product positioning and target product profile.
- Track progress against the development plan; notify of delays/changes.
- Document and track program budget with Finance and project manager; ensure contracts and costs are recorded accurately and timely.
- Assess product development risks with senior management; compile risk mitigation and scenario plans.
- Conduct regular reviews to ensure appropriate program documentation, and monitor progress, scope, timelines and budget.
- Keep program team and executive informed of status, costs and risks.
- Support Project Managers in preparing periodic reports to internal stakeholders.
- Contribute to definition and delivery of corporate objectives; prepare timely and accurate management reports.
- Maintain current awareness of program-related scientific, clinical and commercial knowledge.
Education & Experience:
- Bachelorโs degree required; Masterโs or PhD strongly preferred.
- 10+ years pharmaceutical/biotechnology experience including direct oncology drug development required.
- 5+ years project and budget management experience.
- Non-clinical through Phase 4 experience is an asset.
- Diagnostics experience preferred.
- Understanding of regulatory environment in US, EU and APAC.
- Experience working as part of, and managing, cross-functional teams.
- Line management experience strongly preferred.
Key Capabilities:
- Inclusive mindset; creativity and innovation; commitment to excellence; results-oriented; ethical behavior; adaptability.
- Strong communication and collaboration skills; resilience; continuous learning.